Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma

Completed

• Conditions: Stage IV Skin Melanoma

• Registration Number: NCT01960634
• Lead Sponsor: Grupo Español Multidisciplinar de Melanoma

Brief Summary

This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples.

Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice.

The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Status Verified: 2015-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Confirmed diagnosis of melanoma and BRAFV600
• Signed Informed Consent Form
• Unresectable phase III or phase IV melanoma
• The patients should be starting a treatment for melanoma (either first line or subsequent lines)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of patient in which BRAF V600 in blood samples is present/absent	two years

Secondary Outcome Measures

Name	Time	Method
Rate of patients with BRAFV600 present in tumor sample vs blood sample	two years

Trial Locations

Locations (13)

Hospital Infanta Cristina; 🇪🇸 Madrid, Badajoz, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Insular de Gran Canaria; 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Costa del SOl; 🇪🇸 Marbella, Málaga, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario Quirón Dexeus; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Marques de Valdecilla; 🇪🇸 Santander, Spain

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